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Thursday, November 5, 2015

New Muscle Spasticity Therapy Under Priority Review by FDA

PathMaker's MyoRegulator seen as potential therapy for multiple sclerosis and like disorders

November 2nd, 2015

<span class="entry-title">New Muscle Spasticity Therapy Under Priority Review by FDA</span><span class="entry-subtitle">PathMaker's MyoRegulator seen as potential therapy for multiple sclerosis and like disorders</span>

PathMaker Neurosystems Inc., a clinical-stage neuromodulation company focused on non-invasive therapies for neuromotor disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted the company’s MyoRegulator™ PM-2200 system the Expedited Access Pathway (EAP) designation and priority processing status.
The MyoRegulator is the first product of PathMaker and it is being developed for the treatment of muscle spasticity, a muscle control disorder characterized by muscle stiffness or tightness that causes an inability to control the affected muscles. Muscle spasticity is a condition associated with several neurological disorders including multiple sclerosis.
The management of spasticity can be a challenge and it currently represents an unmet medical need. Surgical, physical and pharmacological treatments for spasticity have short-term efficacy, at best, and can cause some adverse effects.
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